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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K230633
Device Name APOLLO ADVANTAGE Nitrile Examination Gloves
Applicant
Dell Corning Corporation
575 John Dodd Rd.
Spartanburg,  SC  29303
Applicant Contact Sam Chebeir
Correspondent
Dell Corning Asia Co., Ltd.
12e, 7th Floor, Bank Of China Tower, Qingshan District
Wuhan,  CN 430000
Correspondent Contact Yiren Qiao
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/07/2023
Decision Date 06/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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